Intermacs collects clinical data relevant to mechanical circulatory support devices (MCSDs) from index hospitalization through follow-up evaluations. Post implant follow-up data is collected at 1 week, 1 month, 3 months, 6 months and every 6 months thereafter. Major outcomes after implant, e.g., death, explant, rehospitalization and adverse events, are entered within 30 days of occurrence and also as part of the defined follow-up scheduled intervals.
Intermacs provides contemporary data to demonstrate outcomes, with additional insight into appropriate risk stratification and patient selection. Death, transplant, and explant are the major discrete endpoints recorded. Complex endpoints include the patient’s level of function and quality of life, critical to the evaluation of current MCSD therapy these indices are becoming increasingly important as patient survival improves, and new devices will be compared for outcomes beyond survival.
Sponsored by The National Heart, Lung and Blood Institute (NHLBI) and housed at the University of Alabama at Birmingham, Intermacs launched in June 2006 with 15 participating hospitals within the United States. The registry has quickly grown to include the majority of MCSD centers in the U.S. Intermacs is recognized as the Joint Commission mandated registry for all U.S. centers implanting MCSDs for destination therapy and now has expanded to include all interested hospitals in the United States and Canada.
Datasets for Participating Centers
Since 2011 Intermacs has provided participating centers with datasets of their own data via a request form downloaded from the Intermacs website. Due to significant increase in the number of requests, we have designed a method to more efficiently distribute these datasets. Our programmers have found some issues concerning transfer patients captured in the web based data entry, so there will be a delay in distributing these datasets while our regulatory staff reconcile these transfer patients information. Intermacs must follow all FISMA, NIH and PHI regulations and therefore must investigate and resolve this issue before any data is sent out to the sites. Once this issue is resolved with the projected timeline of July 2015, Site Administrators will have the option to download their site’s SAS datasets each quarter in the same manner they obtain the Intermacs Quarterly Site Reports.
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Intermacs is sensitive to site and participant confidentiality. Please use a secure e-mail to communicate confidential information with Intermacs staff. If you do not have a secure e-mail available, contact us at email@example.com and request access to the Intermacs secure e-mail.
This project has been funded in whole or in part with Federal funds from the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, under Contract Number HHSN268201100025C.